Regeneron, Sanofi Get EC Nod For Label Expansion Of Praluent

Regeneron Pharmaceuticals, Inc. (NASDAQ:REGN) announced that the European Commission (EC) has approved a label expansion of its PCSK9 inhibitor, Praluent.

The drug’s label has been expanded to reduce cardiovascular (CV) risk in adults with established atherosclerotic CV disease (ASCVD) by lowering low-density lipoprotein cholesterol (LDL-C) levels as an adjunct to correction of other risk factors.

The trial met its primary endpoint, showing that Praluent significantly reduced the relative risk of major adverse CV events (MACE) by 15% in patients who had suffered a recent ACS. The data also showed that MACE occurred in 9.5% of patients in the Praluent group compared with 11.1% in the placebo group. Moreover, Praluent was associated with a 15% lower risk of death from any cause. Adverse events were similar in the Praluent and placebo groups, except for injection site reactions.

We note that Praluent is already approved in the EU for heterozygous familial hypercholesterolemia (HeFH) or clinical ASCVD (in adults). The drug is also approved for use as an adjunct to diet and maximally tolerated statin therapy for the treatment of adults with HeFH or clinical ASCVD who require additional lowering of LDL-C in the United States.

We remind investors that data from ODYSSEY OUTCOMES have also been submitted to the FDA and the regulatory body has set a target action date of Apr 28, 2019.

Regeneron has a collaboration agreement with Sanofi (NASDAQ:SNY) for Praluent. The label expansion of the drug should further boost sales.

Earlier, both the companies decided to implement a 60% cut in U.S. list price of Praluent, following a similar action last year by rival Amgen, Inc. (NASDAQ:AMGN) to cut the U.S. list price of its PCSK9 inhibitor, Repatha by 60% to improve access and affordability.

Regeneron inked another collaboration agreement with Sanofi, per which the latter records sales for commercialized products (Dupixent, Praluent and Kevzara) and the former has the right to co-promote such products on a country-by-country basis. Regeneron has exercised its option to co-promote Dupixent, Praluent and Kevzara in the United States.

Regeneron’s stock has gained 20.7% in the past twelve months, against the industry’s decline of 13.2%.

While the overall biotech sector was in doldrums in 2018, Regeneron’s performance has been steady, backed by strong growth of two drugs — Eylea and Dupixent. Eylea continues to drive sales, and label expansion of the drug into additional indications has further boosted growth in 2018.

The company has co-developed Eylea with the HealthCare unit of Bayer (DE:BAYGN) AG (OTC:BAYRY) .

Zacks Rank

Regeneron currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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